Responsible for reviewing of all study related documentation to ensure the quality, reliability, accuracy, completeness and consistency according to Protocol, SOPs and Regulatory requirements. Other responsibilities as assigned.

Duties and Responsibilities:

Review study files after completion and ensure that they are accurate and legible according to protocol, SOPs and regulations

Ensure all prepared study source documents and/or forms are in accordance to protocols, SOPs and regulations

Work closely with CRCs to ensure studies are conducted properly with high quality and high efficiency

Observe, on the random basis, clinical procedures during the conduct of studies, sample bundling and shipping process

Provide reports of the reviewed data to relevant personnel/department

Performs other tasks and projects as assigned

Develop and utilize QC Checklist or other QC tools designed to document the QC review process

Assist with training of new QC Data Reviewer Staff

Participate in review of SOP’s and Protocols

Ensure the conduct of clinical trial according the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, Protocol and Biopharma Services Inc SOP’s at all times (copied from CRC’s responsibility)

Qualifications:

Post-secondary degree in a science or healthcare related discipline, or equivalent work experience.

1-2 years of relevant clinical research experience, knowledge of ICH-GCPs and professional experience working in CRO

Ability to accommodate a flexible work schedule and to adapt to changing priorities; able to work under pressure.

To prepare proposals, budgets, estimate schedules and provide contract details related to a Phase I/BE study program from inception (i.e. Study award) to completion. Maintain awareness of overall study requirements in accordance with finalized protocol and ensure incorporated in proposals.

General Responsibilities:

Create and develop BE quotations for review by the Manager, Project Management or delegate and receive appropriate signatures as required

Follow up with existing accounts on new business opportunities and manage activities around outstanding quotations, Confidentiality Agreements, Contracts etc.

Provide input on all departmental reports and databases; ensure that they are updated accurately and issued in a timeline fashion (includes quotation and contract templates, weekly tracking reports, financial reports etc.)

Assist in the preparation and maintenance of all departmental reports and all tracking databases; ensure that they are updated accurately and issued in a timeline fashion (includes quotation and contract templates, weekly tracking reports, financial reports etc.)

If required, assist in promotion of BPSI at industry meetings and trade shows Administrative functions, as required by the position, will include, but will not be limited to data entry, filing, Business Development support, and assisting with Business Development and Marketing related activities as directed by the Vice President of Business Development or Manager of Project Management.

Coordinate client visits and follow up on the requested documents from clients including brochures, validation reports and regulatory documents.

Qualifications:

Bachelor of Science (B.Sc.) degree or equivalent

Relevant background in the healthcare, pharmaceutical industry

Familiarity with the management of all phase I/BE

Demonstrated experience dealing with a wide variety of project stakeholders at all levels in and across various organizational departments

Renzo Dicarlo, CEO shared “The passion and dedication of the BioPharma Services team to building and maintaining long lasting relationships through quality service and reliable research results is humbling. Their unwavering commitment to our clients is evident by receiving awards in these four categories.”

For the 2018 CRO Leadership Awards, Life Science Leader magazine once again teamed up with Industry Standard Research (ISR) to determine the award recipients. More than 70 contract research organizations were assessed on 25+ performance metrics in ISR’s annual CRO Quality Benchmarking survey.

“Industry Standard Research is honored to conduct the research for Life Science Leader’s CRO Awards. ISR’s stringent screening processes and the high caliber of qualification required to participate in our CRO benchmarking research means that real customers provide experiential feedback on their involvement with contract suppliers over the past 18 months. This enables users of ISR’s research to make confident business decisions based on the experiences of their industry peers” said Andrew Schafer, President of Industry Standard Research.

BioPharma Services Inc. is a full ­service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with a total capacity of 300 beds with access to healthy volunteers and special populations. Headquartered in Toronto, Canada, BioPharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Medical Writing and Data Management.

Assists with dispensing, appropriate control, inventory, storage and record keeping of study drug(s) as required

Maintains study files for each clinical trial and performs detailed review of created and prepare by Study Preparation Associates subject and study source documentation and/or CRFs, as well as of completed Source Documents and CRFs

Participates in development, revision and implementation of clinical, general and other applicable SOPs, Directives and internal procedures as required, ensuring consistency with GCP, regulatory, and/or Sponsor requirements

Ensures the accuracy of the generated data in accordance with protocols, ICH, GCP and applicable regulatory agencies

Maintains adequate, accurate, complete and legible records

Collaborates with QC and QA during audits and audit Follow-ups Maintains current professional knowledge base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)

Participate in staff training sessions

Performs other tasks as assigned and as training and experience allow

Qualifications:

Completed postsecondary degree in a science or healthcare related discipline, or equivalent work experience.